Manufacturing Process Specialist

2 weeks ago

Durham, North Carolina, United States ILC Dover LP Full time
Job Overview

Position Summary:

The Process Engineer within the PharmBio division plays a crucial role in supporting the daily operations of pharmaceutical containment manufacturing. This role requires a thorough understanding of ILC Dover's quality systems to ensure adherence to ILC Dover, ISO 9001, and customer-specific standards. The Process Engineer will actively seek out opportunities for continuous improvement and engage in collaborative efforts to implement these enhancements effectively. Additionally, this position may involve direct interactions with clients, including participation in audits and responses to customer inquiries.

Key Responsibilities:

  • Provide expert technical assistance, including the testing and monitoring of equipment, evaluation of current processes, and conducting risk assessments.
  • Ensure comprehensive documentation of all equipment and processes within the manufacturing environment through Standard Operating Procedures (SOPs) and Standard Work (SW).
  • Lead initiatives for continuous improvement by revising, implementing, or developing standard work for SOPs and new operational processes.
  • Support troubleshooting efforts for equipment issues across manufacturing operations, ensuring optimal performance in line with manufacturer specifications.
  • Create new validation protocols informed by risk assessment analyses and manage revalidation activities.
  • Coordinate and lead projects that encompass product development and process optimization.
  • Design, measure, test, and analyze data to enhance production efficiency and improve established systems.
  • Maintain up-to-date knowledge of relevant government and industry quality standards, including ISO 9001:2015.
  • Effectively manage project costs and timelines.
  • Provide detailed documentation and operational instructions for processes conducted in the manufacturing area.

Qualifications:

  • Bachelor's degree in Engineering or a related technical field.
  • A minimum of 5 years of relevant industry experience.
  • Experience with Corrective and Preventive Actions (CAPA), root cause analysis, and 8D methodologies.
  • Certification as a Six Sigma Green Belt or Black Belt.
  • Proficiency in word processing, statistical analysis software (SPC), graphics software, CAD or Auto-CAD, order processing systems, and database management.
  • Strong skills in Microsoft Office Suite.
  • Experience with measurement, calibration, and testing equipment.
  • Demonstrated analytical and problem-solving capabilities.
  • Excellent written and verbal communication skills.
  • Detail-oriented with strong organizational skills.
  • Understanding of general safety and hygiene practices.
  • Able to thrive in a collaborative team environment.

Preferred Qualifications:

  • Master's degree or advanced qualifications in Engineering or a related discipline.
  • Experience in cleanroom and aseptic manufacturing settings.
  • Mechanical aptitude with troubleshooting skills.
  • Familiarity with manufacturing processes and quality standards (ISO 9001:2015, 13485:2016, 21 CFR 820, 21 CFR 211).

Work Environment: The characteristics of the work environment are representative of those encountered while performing the essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. The employee may frequently work near moving mechanical parts and may occasionally be exposed to fumes or airborne particles. The noise level in the work environment is typically moderate.

Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds. Specific vision abilities required include close vision, color vision, distance vision, and depth perception. While performing the duties of this job, the employee is regularly required to walk, talk, or hear. The employee is frequently required to stand; use hands to finger, handle, or feel; and reach with hands and arms. The employee may occasionally be required to sit; stoop, kneel, crouch, or crawl; and taste or smell.

ILC Dover is an Equal Opportunity Employer committed to a diverse workforce. We offer competitive benefits including medical, dental, life insurance, 401(k), PTO, and more.

Background Check & Drug Screening Required

E-Verify Used

EOE/AA Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran

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